N/A
N=239
Confirmatory Efficacy and Safety Trial of Magnetic Seizure Therapy for Depression
Depression · Unipolar Depression · Treatment Resistant Depression
Bottom Line
View on ClinicalTrials.gov: NCT03191058 ↗Enrolled (actual)
239
Serious AEs
4.2%
Results posted
May 2026
Primary outcome: Primary: Remission of Depression on the Hamilton Rating Scale for Depression-24 Item (HRSD-24) — 25; 30 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Magnetic Seizure Therapy (Device); Electroconvulsive Therapy (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Nov 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Remission of Depression on the Hamilton Rating Scale for Depression-24 Item (HRSD-24) |
25; 30 | — |
| PRIMARY Worsening of Autobiographical Memory on the Autobiographical Memory Test (AMT) |
3; 19 | — |
| SECONDARY Remission on the Scale for Suicidal Ideation (SSI) |
44; 36 | — |
| SECONDARY Response on the Hamilton Rating Scale for Depression-24 Item (HRSD-24) |
52; 52 | — |
| SECONDARY Score on the Brief Symptom Inventory Anxiety Section (BSI-A) |
5.2; 6.5 | — |
| SECONDARY Response on the Clinical Global Impression - Improvement Scale (CGI-I) |
21; 13; 27; 37; 31; 26 | — |
| SECONDARY Score on the Quality-of-Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) |
41.3; 42.5 | — |
| SECONDARY Score on the Columbia ECT Subjective Side Effects Schedule (CSSES) |
0.4; 0.5; 0.2; 0.8; 0.6; 0.6 | — |
Summary
This trial aims to assess the efficacy and tolerability of Magnetic Seizure Therapy (MST) as an alternative to electroconvulsive therapy (ECT) for depression. Even with multiple medication trials, 30 - 40% of patients will experience a pharmacologically resistant form of illness. The ineffectiveness of current treatments for major depressive disorder (MDD) coupled with the economic burden associated with the disorder engenders a need for novel therapeutic interventions that can provide greater response and remission rates.
Eligibility Criteria
Inclusion Criteria
Patients will be included if they:
- are inpatients or outpatients;
- are voluntary and competent to consent to treatment and research procedures according to ECT/MST attending psychiatrist;
- have a MINI International Neuropsychiatric Interview diagnosis, Version 6 (MINI-6.0) diagnosis of non-psychotic MDD
- are 18 years of age or older
- have a baseline HRSD-24 score > or = 21;
- are considered to be appropriate to receive convulsive therapy as assessed by an ECT attending psychiatrist and a consultant anaesthesiologist
- are agreeable to keeping their current antidepressant treatment constant during the intervention;
- are likely able to adhere to the intervention schedule;
- meet the MST safety criteria [75];
- If a woman of child-bearing potential: is willing to provide a negative pregnancy test and agrees not to become pregnant during trial participation.
Exclusion Criteria
Patients will be excluded if they:
- have a history of MINI diagnosis of substance dependence or abuse within the past three months;
- have a concomitant major unstable medical illness;
- are pregnant or intend to get pregnant during the study;
- have a MINI diagnosis of any primary psychotic disorder
- have a MINI diagnosis of obsessive compulsive disorder, or post-traumatic stress disorder deemed to be primary and causing more functional impairment than the depressive disorder
- have probable dementia based on study investigator assessment;
- have any significant neurological disorder or condition likely to be associated with increased intracranial pressure or a space occupying brain lesion, e.g., cerebral aneurysm;
- present with a medical condition, a medication, or a laboratory abnormality that could cause a major depressive episode or significant cognitive impairment in the opinion of the investigator (e.g., hypothyroidism with low TSH, rheumatoid arthritis requiring high dose prednisone, or Cushing's disease);
- have an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed;
- require a benzodiazepine with a dose > lorazepam 2 mg/day or equivalent or any anticonvulsant due to the potential of these medications to limit the efficacy of both MST and ECT;
- are unable to communicate in English fluently enough to complete the neuropsychological tests;
- have a non-correctable clinically significant sensory impairment (i.e., cannot hear or see well enough to complete the neuropsychological tests).
Data sourced from ClinicalTrials.gov (NCT03191058). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.